A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood

NCT04714073 | Completed Phase 1 Results

• 2 other identifiers: 1425-00102020-004388-22
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

  Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.

• Maximum Measured Concentration of BI 706321 in Plasma (Cmax)

  Maximum measured concentration of BI 706321 in plasma (Cmax).

  Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.

Study Arms (1)

BI 706321 (Reference (R))/ BI 706321 + Itraconazole (Test (T))

EXPERIMENTAL

On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R). In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)). There was a washout interval of at least 14 days between the administrations of BI 706321 in the 2 trial periods.

Drug: BI 706321; Drug: Itraconazole

Interventions

BI 706321 DRUG

Treatment period 1: Single oral dose of 1 film-coated tablet administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) Treatment period 2: On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet administered with 240 mL of water after an overnight fast of at least 10 h.

BI 706321 (Reference (R))/ BI 706321 + Itraconazole (Test (T))

Itraconazole DRUG

Treatment period 2: Administered as an oral solution formulation once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2.

BI 706321 (Reference (R))/ BI 706321 + Itraconazole (Test (T))

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (body temperature, blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the first treatment period all subjects are planned to undergo the reference treatment (R), and in the second treatment period all subjects are planned to undergo the test treatment (T).

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: February 11, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)